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COMPLETED
NCT05934526
PHASE3

Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

Sponsor: GB002, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2023-12-28

Completion Date

2025-12-22

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

DRUG

Placebo

Matching capsule containing placebo

DRUG

Seralutinib

Capsule containing seralutinib

DEVICE

Generic Dry Powder Inhaler

Generic dry powder inhaler for seralutinib or placebo delivery

Locations (166)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Valley Advanced Lung Diseases Institute

Fresno, California, United States

Keck Medical Center of USC

Los Angeles, California, United States

Dept of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States

University of California, Irvine Medical Center

Orange, California, United States

UC Davis Health

Sacramento, California, United States

Stanford Healthcare

Stanford, California, United States

Winchester Center for Lung Disease

New Haven, Connecticut, United States

The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

University of Florida Clinical Research Center

Gainesville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Northside Hospital Laboratory - Atlanta

Atlanta, Georgia, United States

UI Health Hospital

Chicago, Illinois, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Norton Hospital

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, United States

University of Missouri

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

NYU Langone Health

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

UNC Hospitals

Chapel Hill, North Carolina, United States

Duke University Medical Center - Duke South

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

INTEGRIS Cardiovascular Physicians, LLC

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple Heart and Vascular Institute (Outpatient Clinic)

Philadelphia, Pennsylvania, United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina - Nexus Research Center

Charleston, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

CHI St. Luke's Health Baylor College of Medicine Medical Center

Houston, Texas, United States

Houston Methodist Outpatient Center

Houston, Texas, United States

Baylor Scott & White Medical Center - The Heart Hospital

Plano, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

Advocate Aurora Health-Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Cardiologia Palermo

Buenos Aires, Argentina

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Argentina

Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Corrientes, Argentina

Hospital Privado Centro Medico de Cordóba S.A.

Córdoba, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Argentina

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Sanatorio Parque S.A.

Rosario, Argentina

Hospital Provincial Dr. José María Cullen

Santa Fe, Argentina

St Vincent's Hospital

Melbourne, Victoria, Australia

Wesley Research Institute

Auchenflower, Australia

Royal Hobart Hospital

Hobart, Australia

Nepean Hospital

Kingswood, Australia

Religious Hospital Linz GmbH

Linz, Austria

AKH-Vienna Medical Univesity of Vienna Internal Medicine II-Cardiology

Vienna, Austria

Hôpital Erasme

Anderlecht, Belgium

University Hospitals of Leuven (Campus Gasthuisberg)

Leuven, Belgium

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

Belo Horizonte, Brazil

Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia do Pulmao

Blumenau, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS

Porto Alegre, Brazil

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Núcleo de Gestão de Pesquisa/Hospital São Paulo - SPDM/UNIFESP

São Paulo, Brazil

London Health Science Centre - Victoria Hospital

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Peter Lougheed Center

Calgary, Canada

University Health Network

Toronto, Canada

Enroll SpA

Santiago, Santiago Metropolitan, Chile

Centro de Investigacion Clinica UC-CICUC

Santiago, Chile

Fundación Abood Shaio

Bogotá, Colombia

Fundación Neumologica Colombiana

Bogotá, Colombia

Institut Klinicke a Experimentalni Mediciny

Prague, Czechia

Všeobecná fakultní nemocnice v Praze Il. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hypertenzi

Prague, Czechia

Aarhus Universitetshospital, Department of Cardiology

Aarhus, Denmark

Rigshospitalet, Department of Cardiology

Copenhagen, Denmark

CHU Bicêtre

Le Kremlin-Bicêtre, France

Institut Coeur Poumon

Lille, France

CHU de Montpellier

Montpellier, France

Hôpital Pasteur

Nice, France

CHU de Poitiers

Poitiers, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois

Vandœuvre-lès-Nancy, France

DRK Kliniken Berlin Westend

Berlin, Germany

Zentrum fur Pulmona le Hypertonie, Klini k Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternlstische lntensiv medizin), Herzzentrum der Universitat zu Koln

Cologne, Germany

Universitatsklinikum Dresden, Medizinische Klinik / Pneumologisches Studiensekretariat

Dresden, Germany

Universitatsklinikum Giessen und Marburg GmbH Zentrum fur Innere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie

Giessen, Germany

Universitätsklinikum Greifswald Klinik und Poliklinik für Innere Medizin B

Greifswald, Germany

Universitätsklinikum Halle (Saale) / Martin-Luther-Universität Halle- Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I

Halle, Germany

Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie

Heidelberg, Germany

Krankenhaus Neuwittelsbach

Munich, Germany

Klinikum der LMU Medizinische Klinik und Poliklinik V

München, Germany

Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin

Würzburg, Germany

"Evangelismos" General Hospital, 1st Department of Clinical Care & Pulmonary Hypertension Clinic

Athens, Greece

ATTIKON University Hospital, 2nd Critical Care Department

Athens, Greece

Onassis Cardiac Surgery Center

Kallithea, Greece

AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic

Thessaloniki, Greece

Mater Misericordiae University Hospital, Respiratory Department

Dublin, Ireland

Lady Davis Carmel Medical Center

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

IRCCS Azienda Ospedaliero Universitaria Di Bologna Policlinico 5 Orsola Malpighi - U.O.C. Cardiologia

Bologna, Italy

Azienda Ospedaliera Dei Colli - Ospedale Monaldi Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare

Naples, Italy

Fondazione IRCCS Policlinico San Matteo - U.O. di Cardiologia

Pavia, Italy

Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione

Rome, Italy

Azienda Sanitaria Universitaria Giuliano Isontina /ASUGI - Ospedale di Cattinara - Cardiovascular Department Coronary Intensive Care Unit

Trieste, Italy

Kyushu University Hospital

Fukuoka, Japan

Kurume University Hospital

Kurume, Japan

Nagoya University Hospital

Nagoya, Japan

NHO Okayama Medical Center

Okayama, Japan

Keio University Hospital

Shinjuku-Ku, Japan

National Cerebral and Cardiovascular Center

Suita, Japan

Kyorin University Hospital

Tokyo, Japan

University of Tokyo Hospital

Tokyo, Japan

Pauls Stradins Clinical University Hospital

Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania

Instituto nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico

Hospital Universitario Dr. José Eleuterio González Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas

Monterrey, Mexico

Unidad de Investigacion Clinica en Medicina, S.C.

Monterrey, Mexico

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

Erasmus MC

Rotterdam, Netherlands

Krakowski Szpital Specjalistyczny Im. Św. Jana Pawła II Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego

Krakow, Poland

Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny

Otwock, Poland

Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal

Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente

Lisbon, Portugal

Centro Hospitalar Universitário de Santo António

Porto, Portugal

Emergency Institute of Cardiovascular Diseases "Prof. Dr. C.C. Iliescu" Bucharest, Cardiology 2

Bucharest, Romania

"Niculae Stanciolu" Emergency Heart Institute for Cardivascular Diseases

Cluj-Napoca, Romania

Mediprax Centrum S.R.L

Cluj-Napoca, Romania

Targu-Mures Emergency Clinical County Hospital, Internal Medicine II

Târgu Mureş, Romania

King Fahad Medical City

Riyadh, Saudi Arabia

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

Institute for Cardiovascular Diseases "Dedinje" Clinic for Cardiology

Belgrade, Serbia

University Clinical Centre of Serbia, Cardiology Clinic

Belgrade, Serbia

National Heart Centre Singapore

Singapore, Singapore

National University Heart Centre Singapore

Singapore, Singapore

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System Seoul

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary´s Hospital

Seoul, South Korea

Hospital Clinic I Provincial

Barcelona, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, Spain

Hospital Costa del Sol

Marbella, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Universitario de Toledo

Toledo, Spain

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Golden Jubilee National Hospital, Agamemnon Street

Clydebank, United Kingdom

Hammersmith Hospital

London, United Kingdom

Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street

London, United Kingdom

Royal Free Hospital

London, United Kingdom

Freeman Hospital

Newcastle, United Kingdom

Sheffield Clinical Research Facility, Royal Hallamshire Hospital

Sheffield, United Kingdom